Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)

NCT00852059 | Terminated Phase 4

• 1 other identifier: JoGu_KJP_ASTA-3285-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study determined to measure non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS). Study Design:

• prospective
• multi-centric
• open-label
• randomized
• active-controlled trial

Conditions

ADHD

Keywords

ADHD; children; adolescents; methylphenidate; adherence; immediate release; extended release; efficacy

Outcome Measures

Primary Outcomes (1)

• Non-adherence assessed by the number of non-adherent days during the clinical trial of 100 days using the Medication Event Monitoring System (MEMS)

  100 days

Secondary Outcomes (4)

• Number of non-adherent days measured by pill count

  100 days

• Time interval until a total number of 30 days of non-adherence is reached cumulatively during the clinical trial measured by MEMS

  100 days

• Quality of life during measured by Child Health Illness Profile - Child Edition (CHIP-CE) Score

  100 days

• The efficacy of stimulant treatment during the clinical trial measured by ADHD-Rating Scale- Parent Version Sum Score

  100 days

Study Arms (2)

Immediate release

EXPERIMENTAL

Treatment with immediate release (IR) methylphenidate (Medikinet®) in the morning and 3-4 h later (twice a day)

Drug: Immediate release methylphenidate (Medikinet®)

Extended release

ACTIVE COMPARATOR

Treatment with extended release (ER) methylphenidate (Medikinet reatard®) applied with breakfast(once daily)

Drug: Extended release methylphenidate (Medikinet retard®)

Interventions

Immediate release methylphenidate (Medikinet®) DRUG

Treatment: methylphenidate in the morning and 3-4 h later (twice daily), immediate release

Also known as: Medikinet®

Immediate release

Extended release methylphenidate (Medikinet retard®) DRUG

Treatment: methylphenidate applied with breakfast(once daily), extended release

Also known as: Medikinet retard®

Extended release

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent (separately for children aged 6-11 years and 12-17 years)
• Children and adolescents of both sexes aged 6 - 17 years
• Confirmed diagnosis of ADHD by semi structured-clinical interview K-SADS
• ADHDRS-IV-Parent Version (18-Item-Scale) raw score ≥ 1,5 SD above norm under non-medicated conditions (either drug holiday or prior to medication within the past 6 months)
• Effective treatment with a stable dose of methylphenidate for at least one month (max. 60 mg/day) proved by a 25% symptom reduction in ADHD-RS under medication, compared to retrospective ADHD-RS without medication within the past 6 months.
• Acceptance and capability to swallow capsules of product size, proved by an equally sized placebo provided by Medice®.
• Sufficient knowledge of the German language
• Adequate contraception in case of sexual activity

You may not qualify if:

• Contraindications against methylphenidate
• Previous stable methylphenidate intake more than twice daily
• All severe psychiatric disorders except oppositional defiant disorder (ODD) or conduct disorder. In order to reflect the usual co-morbid spectrum of ADHD, mild or moderate anxiety or depressive disorders are accepted in the study.
• All severe somatic diseases as assessed by the baseline examination or medical history (including life-time history of epileptic disorders)
• Pathological results for vital signs, blood pressure and pulse
• Reported pathological results for ECG during the last 12 months
• Reported pathological results for differential blood count and hepatic metabolism during the last 6 months
• Indication for hospitalization
• Suicidality (assessed by MADRS Item 10, Score ≥ 3)
• IQ \< 70 (clinically assessed)
• Any psychotropic co-medication
• Detention in an institution on official or judicial ruling
• Unwillingness to transmit pseudonym data according to German regulations
• Simultaneous participation in another clinical trial according to German Drug Law (AMG)

Sponsors & Collaborators

• Prof. Huss: lead

Study Sites (1)

Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Körperschaft des öffentlichen Rechts

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michael Huss, Prof. Dr.

  Johannes Gutenberg University, Mainz, Dep. of Child and Adolescent Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Michael Huss

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

DE (1)